Home : Disability News : Medical News and Research By Roche - 2009-01-03
New data shows ACTEMRA inhibits progression of joint
destruction and improves physical function of patients with Rheumatoid
Arthritis.
Fifth phase III study also confirms significant rate of disease remission in patients treated with ACTEMRA
Roche announced today that the innovative new therapy ACTEMRA
(tocilizumab) can significantly inhibit structural damage to joints in
patients with rheumatoid arthritis
(RA) – this is a critical measure of effectiveness of an RA treatment.
ACTEMRA was also found to improve the patients’ physical function after
one year of therapy and to significantly increase the disease remission
rate.
The results from the LITHE1 trial, being presented at the
American College of Rheumatology (ACR) Annual Scientific Meeting in San
Francisco, showed that:
* A greater proportion of patients treated with ACTEMRA in
combination with a commonly used RA drug called methotrexate (MTX)
benefited from a significant inhibition of structural damage during 12
months of therapy compared to patients treated with MTX alone. The
outcome was determined by x-ray evidence of the progression of bone
erosions and narrowing of joint spaces. This benefit is important to
patients as damage to the joints caused by the disease leads to the
disability and pain associated with RA.
* ACTEMRA improved the patients’ ability to perform normal daily
activities, as assessed by the Health Assessment Questionnaire (HAQ)2,
leading to a better quality of life.
* Significantly more patients treated with ACTEMRA achieved
remission* than those treated with MTX alone (47% vs. 8%). The
improvement in remission at one year reinforces the strong remission
data seen at 6 months in four additional ACTEMRA phase III trials
across multiple RA patient populations.
“The outcome of this study is good news for RA patients as
presently many either fail to achieve an adequate response or cannot
tolerate therapies currently available,” said William M. Burns, Head of the Roche Pharma Division. “New
treatment options are needed, particularly those that can target
different pathways to bring relief and inhibit joint damage in patients
suffering from RA.”
“The LITHE study demonstrated that treatment with ACTEMRA
inhibited structural joint damage, which is a major cause of disability
and loss of physical function for RA patients,” said Joel Kremer,
M.D., investigator in the LITHE study and Director of Research at The
Center for Rheumatology in Albany, New York. “It is critical to stop
joint damage as quickly as possible to avoid joint deformity and to
help patients maintain their quality of life.”
In the LITHE study, ACTEMRA was generally well tolerated and the
overall safety profile after 12 months of treatment was consistent with
previously reported 6 month trial data.
ACTEMRA is the first of a new class of drug with a novel mechanism
of action that brings new hope to RA patients. It is a humanized
interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody which
works by suppressing the activity of IL-6, an important trigger of the
inflammatory process. This novel mode of action reduces inflammation of
the joints and relieves the systemic effects of RA.
*defined by the recognised measure DAS28<2.6
Rheumatoid Arthritis - A High Unmet Medical Need
Rheumatoid arthritis is thought to affect over 21 million people worldwide.
It is a progressive autoimmune disease characterized by inflammation
of the membrane lining in the joints throughout the body. This
inflammation causes distortion of the joint and impaired function
accompanied by pain, stiffness and swelling and ultimately leading to
irreversible joint destruction and disability. In addition, the
systemic symptoms of RA include fatigue, anaemia, osteoporosis and may
contribute to shortening life expectancy by affecting major organ
systems. After 10 years, less than 50% of patients can continue to work
or function normally on a daily basis.
About the LITHE study
The LITHE study, a randomized, double-blind, placebo-controlled
trial was designed to evaluate the efficacy of TCZ plus MTX in
preventing structural joint damage and improving physical function.
LITHE is an international study, including 15 countries and 1196
patients with moderate to severe RA who had an inadequate response to
MTX.
In this randomized study, patients received either ACTEMRA (4 mg/kg
or 8 mg/kg, one infusion every four weeks) in combination with
methotrexate or methotrexate alone. The results presented are from a
planned 12-month analysis of a 2-year study. At 52 weeks, total
Genant-modified Sharp Score change from baseline for the ACTEMRA 8mg +
MTX, 4mg +MTX, and MTX alone groups were: 0.29, 0.34 and 1.1
respectively. The percentage of patients achieving no progression in
total Genant-modified Sharp Score were 85%, 81% and 67%.The HAQ-DI AUC
change from baseline, adjusted mean scores were: -144.1, -128.4 and
-58.1 respectively. DAS28 clinical remission (<2.6) was 47%, 30% and
8%.
About ACTEMRA
ACTEMRA is the result of research collaboration by Chugai and is
being co-developed globally with Chugai. ACTEMRA is the first humanized
interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. An
extensive clinical development program of five Phase III trials was
designed to evaluate clinical findings of ACTEMRA. The five studies
have reported meeting their primary endpoints. In Japan, ACTEMRA was
launched by Chugai in June 2005 as a therapy for Castleman's disease;
in April 2008, additional indications for rheumatoid arthritis,
polyarticular-course juvenile idiopathic arthritis and systemic-onset
juvenile idiopathic arthritis were also approved in Japan.
ACTEMRA is generally well tolerated. The overall safety profile of
ACTEMRA is consistent across all global clinical studies. The serious
adverse reactions reported in ACTEMRA clinical studies include serious
infections, gastrointestinal perforations and hypersensitivity
reactions including anaphylaxis. The most common adverse reactions
reported in clinical studies were upper respiratory tract infection,
nasopharyngitis, headache, hypertension and increased ALT. Increases in
liver enzymes (ALT and AST) were seen in patients; these increases were
generally mild and reversible, with no evidence of hepatic injuries.
Laboratory changes, including increases in lipids (total cholesterol,
LDL, HDL, triglycerides) and decreases in neutrophils and platelets,
were seen in patients without association with clinical outcomes.
Treatments that suppress the immune system, such as ACTEMRA, may cause
an increase in the risk of malignancies.
About Roche in rheumatoid arthritis
One of the most important drivers for growth at Roche over the next
few years is expected to be the company’s emerging franchise in
autoimmune diseases with rheumatoid arthritis as the first indication.
Following the launch of MabThera (rituximab) there are a number of
projects in development, potentially allowing Roche to build on further
opportunities. MabThera is the first and only selective B-cell therapy
for RA, providing a fundamentally different treatment approach by
targeting B cells, one of the key players in the pathogenesis of RA.
ACTEMRA is Roche’s second novel medicine and is a humanised monoclonal
antibody to the interleukin-6 (IL-6) receptor, inhibiting the activity
of IL-6 , a protein that plays a major role in the RA inflammation
process. Additional projects creating a rich pipeline include compounds
in Phase I, II and III clinical trials. Notably, ocrelizumab, a
humanised anti-CD20 antibody, has entered phase III development for RA.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s
leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. As the world’s biggest biotech company
and an innovator of products and services for the early detection,
prevention, diagnosis and treatment of diseases, the Group contributes
on a broad range of fronts to improving people’s health and quality of
life. Roche is the world leader in in-vitro diagnostics and drugs for
cancer and transplantation, and is a market leader in virology. It is
also active in other major therapeutic areas such as autoimmune
diseases, inflammatory and metabolic disorders and diseases of the
central nervous system. In 2007 sales by the Pharmaceuticals Division
totalled 36.8 billion Swiss francs, and the Diagnostics Division posted
sales of 9.3 billion francs. Roche has R&D agreements and strategic
alliances with numerous partners, including majority ownership
interests in Genentech and Chugai, and invested over 8 billion Swiss
francs in R&D in 2007. Worldwide, the Group employs about 79,000
people. Additional information is available on the Internet at http://www.roche.com/index.html.
All trademarks used or mentioned in this release are protected by law.
References:
1) LITHE refers to the TociLIzumab safety and THE prevention of structural joint damage trial
2) HAQ, or the Health Assessment Questionnaire Disability Index, is
a patient self-report functional status (disability) measurement used
to assess the patient’s functional ability and discomfort during the
past week. It is a commonly used instrument in many disease areas,
including RA.
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